Label: BELLA VITA HAND SANITIZER- isopropyl alcohol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 2, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • WHEN USING

    When using this product do not use in or near the eyes. keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age be supervised when using BELLAVITA.
  • Other information

    • Store between 110F (43C)
    • May discolor certain fabrics
  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myrstate, Tocopheryly Acetate, Acrylates/ C 10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum).

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    BELLA VITA HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80309-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80309-007-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - EPOCH Cosmetics and Toiletries Industries LLC (561196517)
    Establishment
    NameAddressID/FEIBusiness Operations
    EPOCH Cosmetics and Toiletries Industries LLC561196517manufacture(80309-007)
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